Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01441661
Other study ID # CFC20110815
Secondary ID
Status Completed
Phase N/A
First received September 26, 2011
Last updated March 15, 2013
Start date November 2007
Est. completion date June 2012

Study information

Verified date September 2007
Source Cancer Foundation, China
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical Trial Summary

This non-interventional study includes patients with advanced renal cell carcinoma who are treated with Sunitinib alone or combined with other systemic therapies. The aim of the trial is to increase knowledge about usage, dosage, efficacy and safety under conditions of routine use of Sunitinib.


Description:

Because State Food and Drug Administration (SFDA) exempted manufacturers from conducting clinical trials of Sunitinib in China, overall efficacy and safety data of Sunitinib in Chinese patients with renal cell carcinoma were deficiency. The investigators carried out this research project will be sufficient evidence, and help clinicians in China to make decision in real daily practice.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Histologically or cytologically confirmed, unresectable advanced renal cell carcinoma;

- Sunitinib as first-line treatment alone or combined with other therapies.

Exclusion Criteria:

- History of Grade 3/4 severe allergic reaction to Sunitinib or its metabolites

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
China Cancer Institute and Hospital, Chinese Academy of Medical Sciences Beijing Beijing
China Tongji Hospital, Tongji Medical College of Hust Wuhan Hubei

Sponsors (2)

Lead Sponsor Collaborator
Cancer Foundation, China Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disease control rate (DCR) To determine the Disease control rate (DCR) defined as the percentage of patients who have a partial response (CR) or complete response (PR) to Sunitinib plus those whose disease is stable (DS).
To determine the Objective Responsive Rate (ORR) defined as the percentage of patients who have a partial response (PR) or complete response (CR) to Sunitinib.
2008-2011 (up to 3 years) No
Secondary Progression Free survival (PFS) • To assess the Progression Free survival (PFS) as defined by time interval from date of first dose of Sunitinib to date of the progression of cancer or date of death due to any reasons whichever appears earlier. 2008 - 2011 (up to 3 years) No
Secondary Overall Survival (OS) • To evaluate Overall Survival (OS) as defined by time interval from date of first dose of Sunitinib to date of death due to any reason. 2008 - 2011 (up to 3 years) No
Secondary Number of patients with adverse events • To evaluate Safety of Sunitinib. Adverse events were graded according to the National Cancer Institute issued the Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. 2008 - 2011 (up to 3 years) Yes
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04987203 - Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma Phase 3
Recruiting NCT06391879 - Establishment of a Multidimensional Prediction Model for the Natural Course of VHL Disease-related Renal Cell Carcinoma
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Terminated NCT03655613 - APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC Phase 1/Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Withdrawn NCT05418387 - A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona N/A
Recruiting NCT04623502 - An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy N/A
Completed NCT02853344 - Study of Pembrolizumab (MK-3475) Monotherapy in Locally Advanced/Metastatic Renal Cell Carcinoma (MK-3475-427/KEYNOTE-427) Phase 2
Terminated NCT04088500 - A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma Phase 2
Completed NCT05070637 - Circulating Tumor Cell Reducing No-touch Nephrectomy N/A
Active, not recruiting NCT03634540 - A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003) Phase 2
Not yet recruiting NCT06049030 - A Study of HS-10516 in Patients With Advanced Clear Cell Renal Cell Carcinoma Phase 1
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Completed NCT01358721 - Phase I Biomarker Study (BMS-936558) Phase 1
Active, not recruiting NCT04503148 - Anesthesia and Cancer Study: Renal Cell Carcinoma N/A
Completed NCT02386826 - INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme Phase 1
Not yet recruiting NCT05808608 - A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma Phase 1/Phase 2
Withdrawn NCT03323710 - Study of Propranolol Plus Sunitinib in First-line Treatment of Metastatic Renal Cell Carcinoma Phase 2
Not yet recruiting NCT02787915 - DC1s-CTL Cellular Therapy for Renal Cell Carcinoma Phase 1/Phase 2